Achieving a Balanced Approach to Technology and Total Quality Management Systems

The Evolution of Manufacturing and Quality Management

The global biopharmaceutical supply chain has become an essential issue in many business and public health sectors. For innovators and marketers of therapeutics treating patients, commitment towards their Quality System is critical to compete internationally. Market demands on product safety and efficacy continually increase and require improved management strategies to meet consumer needs. Large and small companies alike must react to the rapid pace and persistent changes to compliance. Maintaining evidence of compliance with business partners and regulators is critical to support marketing strategy.  Evolving technology in manufacturing and quality management needs to stay within the boundaries of laws and regulations.  For more than 25 years, Arbour Group has worked with biopharmaceutical, medical device, and diagnostic companies to achieve compliance with IT systems, automation, and software applications. 

In recent years, reputable names in the pharmaceutical industry have formed joint ventures and executed mergers that have produced value-added alliances.  Those market expansions have materialized and resulted in multi-billion-dollar market shares. It is not a surprise that successful life science businesses establish robust management systems that enable their staff to handle the fast-paced environment in quality, manufacturing, lab operations, and third-party logistics.  Our team is familiar with all of these areas and performs projects where our life science customers are located across the globe.

A Quality Management Systems Solution

A key to maintaining market leadership in life sciences is launching innovative therapies that prolong and enhance patient's lives.  Pharmaceutical and medical device products that target diseases are many times envisaged as curative. However, this can only be true if the products are reliably produced with full support from an established "Quality System." Otherwise, marketed therapeutics can be potentially detrimental to consumers' and patient's lives. The foundation of Quality Management Systems is focused on putting consumers at the center of the business. A risk-based approach to manufacturing pharmaceutical products assures compliance and delivery of quality healthcare solutions to the market.

Mitigating patient risks and costs while increasing therapeutic benefits in healthcare are the cornerstones of the life sciences industry. However, regulators will find situations that sometimes conflict with these.  Inspections have revealed:

• Short cuts are taken from documented procedures
• Quality investigations that do not identify the root cause
• Attempts to establish a QMS without understanding the product process map

Although these examples may seem to help with cost reduction, organizations often find new issues that negatively impact business operations. Total Quality Management is an embedded design within the organization that:

• Synchronizes quality activities and develops a process approach rather than a procedure-driven culture
• Identifies risk and uses Quality Risk Management as a tool to drive decisions
• Understand technology applications without introducing risk to compliance
• Increase commitment to continuous improvement by supporting internal audits and reinforcing supplier audit management
• Assures quality controls are in place to detect failures and potential non-conformities

Measure Your State of Compliance with Arbour Group

A question then remains.  How does your organization measure up? Are decisions in conflict with business objectives or truly adequately aligned as a patient-centric organization? As quality professionals, our accountability extends to our customers and, most notably to public health. In this age of digital transformation and innovation, it's time to re-discover the life sciences industry beyond compliance!  

Arbour Group will discuss a risk-based approach for managing quality failures and quality events for the next segment on how to drive quality culture and compliant technology systems.

Have questions? Want to discuss a challenging situation?  Are you interested in benchmarking your IT system's state of compliance? Speak with our experts. Arbour Group will help bring clarity to your business compliance needs.

Our next topic in this series will address a risk-based approach for managing quality failures and quality events.